Great, welcome to our Sky and Corazon sponsored webinar. So we're discussing starting an ASC or OBL business, getting it right. We're pleased to be able to offer you this educational webinar. We have a star studded faculty and speaker panel for you, including Aaron Armstrong, the Director of Clinical Research from the Advanced Heart and Vein Center from Denver, Colorado. Lyndon Box, Director of Cardiology at West Valley Medical Center. My friend and colleague, Andrew Klein, Sky Board of Trustees and Piedmont Heart Institute, as well as our consultants from Corazon, including Lori Griffith, Amy Newell, the Senior Vice President, and Kristen Truesdale, the Senior Vice President of Corazon. All three of these interventional cardiologists have an extensive experience in peripheral interventions, which is critical to the success of an ASC. So I'll be the moderator for this session. Andrew Klein will be a panelist and he'll be joining us shortly. We're going to be discussing market trends with Lori Griffith and Kristen Truesdale from Corazon, operationalizing the change to the ASC environment with Lori Griffith and Kristen Truesdale, clinical recommendations from Aaron Armstrong, and ensuring quality from Lyndon Box and Amy Newell. Then we'll have extensive time for panel discussions and to answer any of your questions. So if you have any questions, please put them into the chat or raise your hand and I'll try to read off any of the questions that come up. Next slide. I want to remind you that the Sky Annual Sessions are coming up May 1st and 2nd at Washington Convention Center in Washington, DC. And it's going to be co-sponsored with Corazon and the co-host is going to be Vital Solutions. So there'll be a very important scientific sessions in the heart of Washington, DC where a lot of policy is being made. Thank you very much. And without further ado, we'll just get started with the session. So Lori and I are going to talk about market trends and I'm going to kick it off and turn it over to Lori here. But wanted to go at a very high level. state of the union of outpatient services. And right now, certainly more than 80% of surgeries are performed in an outpatient setting of care. And that's only going to continue to grow. And as you look at the graph on the left-hand side of the screen, the outpatient forecast predicted just in five short years is expected to grow a range of 5 to 10%. And in 10 years, doubling that from 11 to 16%, whereas the inpatient forecast is only only 1% and 2% within that timeframe. And so as we take a look at generally the outpatient environment, there's several different settings of care that exist within that umbrella. You can see that you have the outpatient hospital department, ambulatory surgery centers, your physician office, and even at the home where we're doing in-person and virtual visits, as well as outpatient imaging centers. And as you take a look at the scale or the size of those particular arrows, it highlights where there's more market availability and opportunity. And really none is more significant in that arrow than in the ASC market. Because of all of outpatient surgery being performed, those ASC centers are performing half of those surgeries. And that too will increase exponentially as more centers are being built across the country. And in the last four years, cumulative combined, for every one new hospital, there's seven new ASCs being built. Why? I think we all kind of hear the buzz of the ASCs of why. The primary drivers of those include the aging population, lower cost setting of care, payers are forcing more into the lowest setting of care and lowest cost and high quality of care. You have increased technology, convenient access. I talked about payer issues and pressures. And then kind of the list goes on and on. And we can have a whole talk about those drivers as well. But wanted to focus really in on that ASC environment and what's happening here and such the large growth factor on these particular areas. Kind of the first row I wanted to talk about is the value of the ASC market is in the billions, almost a half a billion dollars in the ASC market. On the dollar side, Medicare puts out in each setting of care, whether that's in the ASC, the physician office, in the hospital setting, every year they do payment updates. And right now for the ASC space, that it was an average increase this past year for what's current in 2025 of about 2.6% in the ASC arena. And you can see in the kind of arrow pointing up that those are some of the services that offer in an ASC. These are the average net revenue per case, and it's scalable. So you have your orthopedic surgeries making the most margins and most revenue per case all the way down into pain management. And what's prevalent here in the ASC space is ownership. And particularly on the physician side, where we see about 68% are physician-only ownership structured. And the other large majority of that is physician and hospital joint ventured ASC centers. However, as we start to see, you know, there's certainly multi-specialty, single specialty, but there's about half are single specialty ASCs. But once you get into the multi-specialty areas, there's a lot of combinations and complements between different specialties. So a lot of what we see are orthopedic and pain together, or orthopedic pain and podiatry together in a specialty ASC. And that's why we're talking here today is that last row. It's all the buzz in terms of cardiology with one being added to the covered procedure list, which we'll talk about here in a second, but that specialties in surgery centers with the highest increase in payments are cardiology are at the top. You can see the other two listed here as well, but it's also the highest facility growth as well. And you can see the predictions there on the slide for what service lines are expected to grow in the ASC space. And you can see cardiology there is around that 15% mark. And I will say, as I mentioned, just to kind of give a state of the union for ASCs, there's about 11,500 ASCs in the United States. About half of those are Medicare certified. Certainly there's states that are larger, that have more ASCs. Top four include California, Texas, Georgia, and Maryland. I think Maryland is tops the list as ASCs per capita, but it is a growing market generally. And here today, we wanted to talk about some of those spotlights within the cardiovascular arena. And so this is relatively new space within the arena. And I'm really talking more on the cardiac side of this bench rather than the peripheral interventions because that's been in the OBL setting of care, the office-based lab care for years. But as states have either sunsetted their certificate of need or changed regulations in their state health plans, more devices got added to the covered procedurals, so pacemakers and ICDs. And then in 2020, cath and PCI got added. So I think that also played into a factor with COVID. It hasn't quite escalated in terms of single specialty cardiac ASCs just yet, but I think we're going to be on the cusp of a boom here to see some of those growth areas and trajectories. But generally, as we take a look at the outpatient profile for cardiovascular procedures, that's already there. That ship has sailed. You're taking a look at cath and PCI, EP, vascular, all of that is primarily outpatient to begin with. And that is where some of those growth factors are occurring on that far left slide in terms of those growth rates. And what that's leaving is hospitals with higher-end acuity cases in structural heart or the complex ablation. Right now, some cardiac imaging, like CTA or coronary CTA, primarily still in the hospital setting, although we're starting to see that movement into the physician office. But as I mentioned, I'd say for the ASC, which was right in the middle, those growth projections are growing in the ASC cardiac space and particularly on the device implants and actually vascular. As I'd mentioned, vascular, if an entree into either an OBL or an ASC space, if you had to pick anything to get into the game, it would be vascular. It's an unregulated, underutilized service. So you can do vascular procedures in any state, in an office-based lab, there's not a lot of regulations around it. And so as we take a look at those kind of growth areas, we'll talk a little bit about some of our other panelists, we'll talk about case selection and some of the clinical guidelines to live by for some of these cardiac cases. And on the far right with the two maps, you can see the change in percentage of outpatient cardiac ASC volume, and it's a heat map. It says, where is this happening across the country? The darker the blue is where more activity and changes in that percentages are higher. So you can see that it pops out there in the slide is around the Phoenix area, which we, our company knows very well that that is a very hotbed area for cardiac ASCs. And I would expect some of these to start to turn a darker shade of blue as we just internally get more calls about this space as well. A lot is happening in Mississippi, in Florida, in Texas. And you can see a lot of the East Coast is still a lighter shade because a lot of regulations still tend to be up and down that East Coast area. And whether or not this is coincidence or not, but there is a factor in here as PE-backed companies are investing in these areas as well. And so there's a lot of PE cardiology investment deals, particularly in those red states with Texas and Florida. And we hear about them, you know, whether you're gay or nay about the PE, it's there. And so it does play into some of that growth trajectory as well. So you've heard from Kristen about the shift of cases to the outpatient setting, but I want to talk a little bit about other reasons why the ASC is an important space. And I'm going to tell you, patients love the ASC. It's so much easier and convenient for them to utilize the ASC. There's easy parking, it's free parking. You can pull up right to the door. You typically have very little wait time. One of the key things about a surgery center is it operates extremely efficiently. So patients have very little wait time, very predictable. It's typically a lower cost or lower out-of-pocket for the patients. It's proven to be very safe, very effective. And I just want to say, it's just gotten such a more personal touch for the patients. I've had some of my nurses tell me, oh, my patient saw me at the gym and knew who I was. So it's your, the patients feel like they're a person rather than a procedure. And from a physician perspective, what I heard from most of my physicians is several things, actually. They can be more efficient in the surgery center as well. They could, surgeons, physicians would tell me I can do three cases at the hospital and maybe be done by 6 p.m. and I can do six or seven cases at the surgery center and still be done by 3 o'clock. So it significantly improves their quality of life. And there's also that opportunity for financial interest and equity in that ASC as ownership. And as Kristen mentioned, the payers definitely like the surgery centers. It's lower cost for them as well. Government is looking at discussing some site neutrality as far as payment structures. And commercial payers are really, really starting to push patients to ASCs as well. And asking providers to justify some procedures why you would need to take it to the hospital and not an ASC. So all of these things together are going to continue to make the ASC a very important piece of anyone's ambulatory strategy. Kind of rounding out the market trends, certainly can't ignore some of these three main points here on the slide, which are related to facility fee restrictions, price transparency and state regulations. In terms of facility fee restrictions, these are state driven. I would say nothing, the only state we know is active is Washington State. There's other states considering really what that means is it's preventing hospitals from charging facility fees at off campus locations. And as it's written, ASCs fall into that category as well. So there are certain states that may have some ASC restrictions related to that. In terms of price transparency, there are a handful of states that are looking to pass legislation to enact price transparency just like it exists on the hospital side. There are a couple states like Colorado where they've recently enacted price estimate requirements. Texas enacted itemized billing requirements. So there is certainly the visibility of the prices at ASCs coming out and would expect that to be continued on in the 2026, whenever that gets published for next year by Medicare. On the right-hand side, though, I do want to strongly encourage if cardiac is a regulated or unregulated in your state, you may or may not know that, but there are state laws that govern licensure and regulations for procedures in the ASC. And right now, about 40% of states across the country allow PCI to be performed in a surgery center. And you can see the legend on this slide, but really the green are where areas that you can do PCI in a surgery center. I highlighted Michigan and Pennsylvania because those are relatively newer states that have passed regulations to do that, whereas kind of the Midwest, particularly Mid-South, has been traditionally an unregulated state overall. And so you can see, like I mentioned, up and down the East Coast, there is higher regulatory requirements with the red right now. Those red states, California, Ohio, Kentucky, are not permissible at all. And so I think if you live in a state, you can certainly look at that sometimes. As Lori and I know very well, sometimes you call the state because sometimes regulations can be a little gray in their wording, and sometimes they may not even know. And so I would say we do have a Rolodex of information if you need clarity on whether or not PCI is allowed in your state, feel free to give us a chat or reach out to us directly, but we can get you what you need if you're interested with that. But as we take a look at operationalizing the change, I'm going to turn it over to Lori in terms of some of the building an ASC and what to consider. So building an ASC is a huge endeavor, and for me, I would say the very first step is developing that business plan, understanding what your costs are going to be, your cost to build the building, your operating expenses, what's your market, how many cases are you going to be able to have, and do that detailed pro forma to understand, does spending this money to develop this ASC, does it make sense? As Kristen mentioned, there's many legal considerations and regulatory requirements, and not only at the state level, at the federal level, and I would say investigate those very carefully before committing down that path. I would also say engage an experienced architect that has built ASCs, particularly if you think, because PCI is not approved in my state yet, I'll build an OBL and then convert it to an ASC when that time comes. It's very expensive to convert your facility to meet ASC standards, so we would strongly recommend think of the future, and if you're going to build a new facility, build to the ASC standards, whether you operate it then as an OBL temporarily, that's a consideration, but you're ready to flip that switch when you can make the change to an ASC. Equipment planning, understanding that building that facility can take up to a year, and if your state is a COM state, it could take even longer, particularly if competitors in your area oppose your building your ASC. So a lot of things to think about, how you're going to set up your ownership, are you going to be one single specialty or multi-specialty, I would say really important is don't overbuild your facility. It's a cost that, you know, if you decide I want to put in four rooms in my ASC and you don't have the volume to fill four rooms, you're going to have very expensive real estate sitting empty, but understand what could be in your future. Setting up the operational structure is very significant, I want to particularly call out Medicare conditions for participation, they're very specific and there is much more regulation to an ASC than there is to an office-based lab. And really important, picking the right team that's going to make you efficient and have experienced staff, and I would also say hire a very strong leader, administrator, and hire them early in your process. There is a lot of regulatory things and structure that need to be put in place before you can open your facility. So I guess three things, the business plan, an experienced architect, and making sure you have that experienced leader in place early in the process. And here's why, the investment to build this facility is significant, it can be upwards of 10 million dollars, you've got significantly expensive equipment that needs to go in a lab, deciding if you want fixed imaging or mobile imaging or maybe both. You have your pre and post areas that you need to have equipment in, your support areas, and understanding again, do you want one lab and shell out a second one for the future. These are things to think about. And we're seeing on average in many areas about 800 per square foot for construction to meet ASE standards. And again, you have that 10 to 12 month timeline. And as I'm sure you all know, there's very specific requirements in square footage and size of your rooms based on what type of procedures you're going to be doing in those rooms, how many pre and post bays you need. These are all regulatory requirements. And again, goes back to hiring that experienced individual that understands these things so you can get it right the first time. I guess you're kind of building that case, getting it right. If you're moving into either considering starting an ASC or an OBL, the top line of your business plan would be revenue. And just wanted to lay out the landscape around the different payment models, particularly for the ASC and OBL. There is one in here that's missing, which is the hospital outpatient area. They follow very similarly to the payment methodology as the ASC. But as you take a look at, I'm going to start from the bottom actually in the OBL setting, that is under the Medicare physician fee schedule. You have your conversion factor for this year for those fees. It was a 2.8 decrease, and that is going to continue. You can see for IR and vascular surgery, there's about an average of a 2% decrease there as well. And from a billing structure standpoint, those are grouped together, meaning the technical portion or the facility fee and the professional fee can be billed together called a global bill. This is billed under a place of service 11. And so as we take a look at that environment, and if you're considering moving from an OBL to an ASC, there is a very different payment structure that occurs there on the facility fee side. You would operate under a model which those are billed separately. So you have your technical component and your professional component. The technical side or the facility fee is billed under place of service 24. All of those rates are set by Medicare. In the ASC space, there is a list that you follow that has called the covered procedure list. It's the CPL list that has a list of all of the CPT codes that are allowable by Medicare to be performed in the surgery center. That list is about 4,100 CPT codes. Every year, they add more and more. This year, they didn't really add anything on the cardiovascular side. I think they added some dental codes and a rotator cuff CPT code. What was disappointing from our end and from other societies like the Heart Rhythm Society is that they were fully lobbying to get low-risk ablations to be added to the covered procedure list for 2025. That did not happen, but that is something that will likely hit that covered procedure list in 2026 if I were to put my vision goggles on of what would be that next type of procedure. Is it allowed over here? Isn't it allowed over here? Is that cluster of procedures that are approved on that covered procedure list in the ASC versus are you allowed to do that in your OBL right now? Diagnostic catheter allowed to be done in both settings. PCI, those with an asterisk are only certain CPT codes, so you're not doing your complex CTOs in the surgery center, but you're doing your single stents and those types of things in the surgery center, but not allowed in the OBL. Peripheral vascular, like I mentioned, can be performed in both. Actually, what I don't have a slide on here, but I want to mention is that peripheral vascular traditionally has paid more favorably in the OBL setting. That's why it was always done in that setting of care. In Medicare for right now for 2025, almost all peripheral vascular, I mean on the arterial side, are more favorable from a revenue payment standpoint on the ASC. I wouldn't be surprised to see some of that shift occur on there as well, so device implants and right now ablations can't be done in either setting up care. This is just as a takeaway, a cheat sheet for you all in terms of that comparison. If you take a look at the first two CPT codes, those are PCIs, you can see this is the technical reimbursement or the facility fee that has nothing to do with your professional component. These are what's different. When everybody says, I'm going to lose all this money taking it out of the hospital into the surgery center, this is what they're referencing. You can visually scale up and down some of these types of cases, but right now, all of these cases are dropping about, I'd say, 30% if you take it out of the hospital and put that same case in the surgery center. That payment is about 30% less. However, I always put this however there too, because the cost structure is completely different on the surgery center side as well. Just like the revenues dropped 30%, well, the cost should be dropping about 30% to 40% also in the surgery center. It's a lower cost setting of care. The contribution margin is really the end game here in terms of financial outlook. This is the last slide in our section, but also I didn't want to ignore that there is this hospital physician partnership, particularly in the ASC space. Some health systems that you can see in just Google and Becker's, they're doubling down on an ambulatory strategy with significant growth in surgery centers. You can see that Banner Health, you have Intermountain Health, Advent Health, they're all moving forward. It's not certainly cardiac specific, but just generally, they know that's where that area is happening. Certainly from a hospital physician partnership, it depends where you're coming from. I do think they're on the consideration side. You can join venture between hospital and physician groups. You can join venture with physician groups at a third-party developer and a management company. You could go at it alone with just physicians. The physicians could be employed or independent, but either which way, the physicians have to be qualified. If they're putting up investment, the investment to build it, like Lori had mentioned earlier, has to coincide with the equity interest into that ASC. Just to be aware, this is out there. It is more prevalent than it is on just certainly the acute care side than for ASCs. Something to think about. Great. Thank you. Thank you so much, Kristen and Lori. Next, we're going to introduce Aaron Armstrong from Advance Heart and Vascular in Denver, Colorado. Aaron has been fortunate enough to work at a VA hospital initially, and then Adventist Health in Northern California, and now at an ambulatory surgery center in Denver, Colorado. I can imagine no one else who's better about discussing the clinical and even the financial considerations for ASCs. Aaron? Thanks very much, Arnold. Appreciate the kind introduction. As Arnold mentioned, I did practice for a number of years in a university and VA-based setting, then in a hospital setting and a service line with Adventist Health, and now I'm in a private practice setting where we actually have our own ambulatory surgical center that's a cardiovascular ASC. A few things I'd like to discuss. I think that was a great background regarding the market trends and the development of cardiovascular ASCs. I think that a lot of why this is possible and why states have had some increased access to the use of cardiovascular ASCs is related to SCI supporting PCI in the ASC setting. SCI published an expert consensus document on length of stay following PCI in 2018, and then subsequently has published some very important, I think, position documents that a lot of payers and others utilize for PCI performance in the ASC setting. I think key to this is looking at the algorithms for which patients can be considered to be safely treated in the ASC setting. This includes a few important aspects we don't always consider when looking at treating patients in the hospital. It includes the adequate social support and access to follow-up care, and also important clinical features, a few of which were mentioned earlier, as well as some anatomic and complexity features. In our own experience in Colorado, when we first started setting up a cardiovascular ASC five years ago, we were a red state in the sense that ASC PCI was not allowed. We actually went to the state and argued with a lot of the information from this position document about the importance of being able to do this. We actually obtained a waiver from the state of Colorado to allow ASC-based PCI. Some of the consensus document highlights look at some of the fact that STEMI and MI care is dictated by state regulations. There are some recommendations regarding staff and physician operator recommendations and expansion of the procedures that can be performed eventually over time in the ASC setting. I think importantly, and this is something we'll talk about later in this talk and Dr. Box as well, quality is a hugely important aspect in the cardiovascular ASC setting. I think especially as these programs are scrutinized with being newer programs, and with the competitive environment of hospitals looking to see what the outcomes look like, it's crucial that the quality in the ASC mirrors the level of what we see in the hospital setting as well. In addition to that, peer review as well to ensure that there's adequate review of cases. Just to show how far things have come, if we look at the recommendations with regards to ASC and OBL-based PCI, the 2014 SC&I document, of course, did not include any of these data, but in the more recent document, there's a lot of guidance. Anyone looking at starting an ASC or getting involved in the space, I think this is a crucial document to review. It includes, obviously, that first and foremost, you have to follow the state certificate of need if there is one. That's not an absolute barrier to having an ASC, but it does create an extra layer of regulation. Case selection, obviously, we're looking for elective PCI, same-day PCI, and careful case selection. The types of equipments and devices that can be utilized. You can utilize stents and covered stents and IVL in the ASC setting. The reimbursement aspect is, of course, another consideration. Then, of course, strongly recommending the use of physiologic testing, including FFR and IVUS in the ASC setting. It's a requirement in RAC, and I would imagine in most cardiovascular ASCs, to have some type of hemodynamic support with a minimum of at least a balloon pump being available, and to have a transfer agreement in place that's formalized with a hospital and with EMS to be able to get patients transferred to a hospital setting, if necessary, within a 30-minute response. In general, I think a good guideline is that newly trained physicians with less than three years experience should not be performing PCI in the ASC setting. This is not to say that it's not possible, but this really should be the type of procedure that's done among people who have significant post-training experience to minimize the likelihood of complications and maximize optimal patient selection. The same is true of staff. Ideally, we want to have staff who have significant experience. Maybe because it's a more elective setting, we're fortunate in the Denver area that I think our cath lab staff in the ASC are actually probably the most experienced ones in the metro Denver area, partly from a quality of life perspective. Then, of course, as I mentioned, recommendations with regards to quality assurance and peer review, especially in considerations of a solo operator. If you look at the volume that we're looking at in ASCs, most ASCs are going to be less than 200 PCIs per year. The case selection is crucial. One thing that the state of Colorado, kind of unique to us perhaps, is that they actually require, because PCI was a new procedure in the ASC setting, to use radial-only access in our state. We're actually not allowed to get thermal access, except in case of emergency in our ASC setting. Interestingly, if we're utilizing the space as an OVL, we are allowed to get thermal access, so it creates kind of an odd dynamic in that regard. Clearly, I think radial PCI, with all the data that's been developed over the last decade or two, is kind of ideal for the ASC setting, as we know that there's fewer bleeding complications, earlier time to ambulation, and faster discharge. Atherectomy was at one point, but is no longer allowed in the ASC setting from a reimbursement standpoint. I think this is reasonable. If you're needing to use atherectomy, the case complexity is likely high enough that it's more reasonable to do it in a hospital-type setting. I'm just going to skip through this here. This is a simplified algorithm for case selection, which I think is helpful. If you're looking at a patient with a planned cath or PCI with an experienced interventional cardiologist, the types of cases that 100% should not be done in the ASC would be last remaining vessel, some kind of a retrograde epicardial CTO, and a patient's a surgical candidate, definitely that should be done at a place, not just in a hospital setting, but probably in a place that has cardiac surgery on site as well. Other things to consider as potential exclusion in the setting of an ASC is patients with significantly decreased LV ejection fraction, some type of planned atherectomy, as I mentioned, unprotected left main, CTO, or vein grafts. These are probably more appropriate to be done at a PCI in a hospital setting, not necessarily where there's cardiac surgery on site, but a high volume place where there's access to human dynamic support such as Impella. And then other patient considerations in the ASC setting includes high transfusion risk, high baseline respiratory risk, patients who have significant chronic kidney disease or high risk for AKI, or high vascular complication risk. Again, these are patients that are more appropriately done more because of the patient characteristics in a hospital setting and not in ASC, primarily because these are the patients who are more likely to have to stay overnight or potentially have some cardiopulmonary complication that would be best handled in a hospital setting with other services available. But assuming patients do not make these high risk anatomic or patient-specific criteria, these are the patients who are definitely a candidate for considering PCI in an ASC setting. So another big consideration in the ASC setting is applying change management tools and principles to bolster throughput, quality, and financial performance. Because we are working in an outpatient setting where patients are not staying overnight, and you're looking at the staffing needs, the throughput is very important. So utilizing frequent team meetings and huddles and highlighting key metrics of different cases, I think, can help optimize the throughput. And the reality is that this requires continuous improvement. I think we all know in a hospital setting, if things are running behind an hour or two, that's probably a usual day, or you might have a STEMI come in. In the ASC, you're looking to staff for a certain period of time. And so even minor improvements accumulate into very significant steps towards process improvement and ultimately better patient outcomes. So this is where the staffing efficiency really comes in as far as standardizing the workflow and cross-training staff. I would say that in our ASC, our staff has much more kind of cross-functional collaboration and ability to kind of function as tech or nurse pre and post. That really helps with the problem solving and the communication. I think this is helped by the fact that we have a more stable staff as well, because these are more experienced staff who have chosen to work in the ASC setting. So a number of other best practices, these could each be a long talk. Inventory management is crucial, because you have to choose which devices you're going to have available. And if you don't have the device there, you can't do the case. And you want to optimize the staffing levels, supplier negotiations. A lot of ASCs partner with certain companies with some of their product lines in order to kind of optimize the efficiency of the payments. And then preventive maintenance and continuous process improvement. So I'm going to go through this a little bit quickly here, because I think Dr. Bach is going to talk some of this too. But quality is just as or more important in the ASC setting as in the hospital setting. And quality broadly encompasses the customer focus, the relationship management, evidence-based decision making, and overall process improvement throughout the kind of episodes of care. And so this is not just the ASC, but quality is a cornerstone for any cardiovascular program in any setting of care. The patient safety really must remain first and foremost. This is just as or more important in the ASC setting. And it's important to have these guidelines. Continuous quality improvement is key. You have to share with key stakeholders, leaders, physician staff, and the patient. So we take very seriously the patient feedback of the experience. In the end, this is a customer service we're providing. And it matters a lot from the time the patient checks in to when they leave the door. And then the follow-up as well with calling patients the next day and ensuring that they had a good experience. So each of these aspects of the program needs to be looked at in order to ensure continuous quality improvement and try to minimize readmission rates and any type of significant complication or mortality. And this ultimately allows opportunities to improve. We don't want to just achieve the benchmark. We want to be excellent. And then it's important to have this concurrent data so you're able to analyze things as they're happening, which then allows you to be proactive. I think if you're in an ASC setting and you're reactive, you're going to run into issues very quickly. So if I go back to this, it just gets again to the fact that we want to be having more experienced operators, very strong patient selection and anatomic selection, and optimize the likelihood of excellent patient outcomes in this setting. Great. Thank you so much, Aaron. We're going to have to move on to Linden and Amy to do over quality. But we definitely want to get back to you because you have the most direct experience. So thank you very much. So Linden, you helped write up the ASC document from Sky and also participated in the PCI without on-site cardiac surgery. Why don't you add on what you would have for ensuring quality in an ASC? You're on mute. Thanks. Okay. Are you seeing my screen there? There we go. All right. So yeah, what I'm going to do here is just sort of elaborate on some of the quality issues that I see as probably the bigger factors or challenges that affect the ASC and nothing to disclose. Before I do that, these papers have already been highlighted, but I'm going to just put the reference up here. I see them as really complimentary works. The first paper that I helped lead was really a reaction to the somewhat of a surprise coverage decision by CMS for PCI in the ambulatory surgery setting. We really wanted to set out some pretty hard concrete guidelines for what that should look like. Then the document that Arnold led in 2023 covered a much broader topic, which was PCI without surgical backup. But within that, there was a section specific to ASC that kind of expanded on the previous document. I see that in my perspective, they're somewhat complimentary and that the second document is an evolution of the first. But I'd say if you're wanting to work in this space, then I would strongly encourage you to have both of these documents available, because it really outlines a lot of everything we're going to allude to here, but in much more detail. As I said, I'm going to elaborate on some of the bigger pain points that come up around quality, the challenges I mean it's easy to talk about these things but in the real world these are the things that can be really challenging so one is relationship with a surgery capable tertiary center. That sounds good we should all get along but if they are a major competitor or perhaps it's the hospital you currently work at and they are not happy that you're opening an ASC. These can be a big barrier and may be difficult to develop that relationship or to have a guaranteed acceptance transfer protocol, a relationship with EMS. They're busy they don't usually transport to an ASC. So that's going to be something we have to go out and really work and meet with them to try to develop those relationships and those protocols. You know I've heard of surgery centers that had a great practice of doing drills with EMS where they bring them in to help do drills on emergency transfers. That's wonderful but that's going to be you know something you're going to have to work at to build that kind of relationship. And then the other one that on both documents we did not feel should be compromised was having adequate equipment and everybody that worked on those documents was well aware of the cost. So you know you have to have emergency capability with balloon pump, you have to have covered stents for perforations, you have to have adequate imaging equipment to get good quality diagnostic images. And both documents were consistent with the strong recommendation of having the ability to do intravascular ultrasound, as well as physiologic assessment. So you know the theme being that the quality should be the same as what's capable in the hospital. Staff and there's been some allusions to this already but just to emphasize the fact that this is for experienced people. I think that the bigger challenge is actually around the physician staff, more than it is around the lab staff because a lot of the lab staff are easily attracted with not having to take STEMI call. So they're ready to move out. But if you already have an established group and you have people that have experience, you know, as far as your physicians, then it's not an issue. But it's not a place to recruit in new physicians. So I think that you know if you don't already have the work pool there it's, it may be difficult to find somebody to bring in. You know it's emphasized in the first document, the second document, this is not a place to train. So it really is, you know, going to be somewhere that you want experienced operators. The quality assurance process, you know, this is a familiar infographic. And I think that the real challenge is that one of the benefits of the Amatory Surgery Center is that it's very efficient, it's very lean. But that makes it difficult to have things like data abstractors or, you know, the quality improvement staff that you have at the hospital that goes and abstracts all the charts for you and helps you prepare your reviews if you're the cath lab director. So that can be something that you know there's not necessarily that people don't want to do it, it's just that they have developed this lean operation structure and they don't necessarily have the resources to do the footwork. And one of the bigger issues in my mind is peer review, you know, we emphasize in both of those documents, the importance of peer review. This is really challenging because by nature, there's going to be most Amatory Surgery Centers are going to have a small number of physicians. So you've got a small cadre of physicians. They're very intertwined, both professionally and financially, many times. So getting objective peer review is going to be very difficult to do internally. It may be difficult to do within the region if you try to outsource it because of competitive issues around the Amatory Surgery Center. But on the other hand, you know, I don't think that we can do good work without some level of peer review. So it's an essential idea and conceptually, it seems that, you know, everybody agrees we need this, but operationally, it can be very difficult to do this in the Amatory Surgery Center. So this is really a good point to transition into, you know, how accreditation or Corazon can help with this type of thing. And this is a partnership between SC&I that really built off of a lot of the guidelines and the work that we've done and how to operationalize that and lead cath labs, ASCs through the process. And really how it helps is in the fact that, you know, they help outline everything, help guide you through the standards, do some of the footwork, as I was talking about with that quality review process, also helps review internally your staff. And then down the road through that ongoing relationship provides a lot of the resources that, you know, you just don't have time. I mean, you don't have the economy of size to maintain a full FTE to do your quality work. You know, that's not going to be the reality for an ASC in most situations. And so this is something where having an accreditation and ongoing relationship can really be helpful. So with that, I think we're going to open it back up. All right, great. So we want to remind you to please put your questions in the chat and then we'll have Amy Newell help me kick off the discussion. Amy, any comments on the presentation so far? Oh, it was a great presentation. Thanks to everyone. I do want to highlight a couple of things, especially what Dr. Bach said regarding, you know, oversight. You know, peer review can be extremely difficult, as can the quality management in the setting of an ASC. And oftentimes, you know, this is where Corazon, a trusted partner, can help in that effort because to have two or three physicians review one another's work, it's great. In concept, but should it be done right? Because you have, there's an inherent bias there among providers. And that's not a bad thing, but oftentimes taking it outside and having that third party review would be critically important. The same for the quality. I mean, many ASCs, it's difficult, it's expensive to participate in a registry, in a national registry. So how can you work with an ASC to build perhaps an internal dashboard or an internal scorecard, you know, to keep an eye on that quality? And again, you're looking for things as major adverse events that you don't want to have happen in an ASC, nor should they. And ensuring that your case selection, that you're adhering to the criteria that Sky has proposed and that you're managing those patients appropriately. But I think all of the physicians here have really done a wonderful job. And, you know, I'm curious to get some feedback from Dr. Klein, even, and some of his experience and what he's doing in his practice as well. Yeah, Dr. Klein, you want to lead off the discussion here? Yeah, no, I, thanks for having me. I agree with the discussions. I think the key here is quality more than anything else. You know, I think we need to, I think it is, you really should be part of a national registry. I think we have to hold each other accountable to this. And even though it may cost more, it really is important that we are critical in making certain that the quality registry is there for vascular space. That it's there for the interventional cardiology space as well as for the EP space. Because I think at the end of the day, we've got to make certain that we're all doing this. Just to harp back on what Erin was talking about, this is definitely not a place to take, you know, new physicians. I think all of us that do interventions know your first five years out are your hardest years. And I think you've got to at least take people that are beyond that. And so, you know, making certain that we stay up on ourselves and make sure we have our peer review is critical. And if you're going to jump into this space, then I think it's critical that we are, that you are also taking on a cost to making sure that your quality performance metrics are being evaluated and that you're getting peer reviewed. Great. Thanks, Drew. So we have a couple of questions in the chat boxes. Lori or Kristen, we have a question. Are there any EP-only ASCs or is it cost-inhibitive given only devices can be performed? Kristen, I guess I'll take this one. I can tell you we are working with a client who's just in the development stage but is planning an EP-only ASC. Obviously, they'll be starting out with devices only, hoping that as Kristen mentioned earlier, 2026, that possibly ablations will be approved. But their whole model is around EP-only with devices. And devices typically, granted the devices are expensive, but there's typically a very good reimbursement on those procedures and they do very well. Yes, agreed. Particularly in the Chicago area, we know one very well there that is EP-only, device-only, but it does, financially, it is profitable. Would it be fair to say that the more specialties you can add in, the lower your risk, however? Yeah, certainly throughput of volume is key here. The more volume you can put in to optimize lab and room utilization, the better. Certainly, there is operational optimization that is just inherent in this setting of care as well. But yes, generally, the more volume, the better, the ROI. Makes sense. Okay, we have another question. Any info on New York State's Certificate of Need status? Anyone from Corazon able to answer that question? Or Lyndon? No. No updates. I think they're still Certificate of Need, right? They're definitely still Certificate of Need for sure. I can pull some of those regs and follow up, particularly in the surgery center. Great, thank you. I'm going to hammer Aaron here with a couple of practical questions since he's actually working in ASC. The first question comes from the audience. What specific guides and wires are cost-effective in an ASC? What company stents do you use? And then I would add, are you locked in with one company for a package deal to get the major discount? Yeah. So, I mean, from the wire and guide perspective, we use kind of similar wires to what we use in the hospital. We have primarily Asahi wires. We use the Shion Blue. We have Fielder XTs. We've got Pilot 200s. You know, kind of a lot of these companies are happy to kind of partner with you in the ASC setting and often offer some of these devices at significant discount to the hospital setting. So we actually have a pretty good line of wires, which I think is key. And then kind of the usual EBU, JR guides, AL guides, and whatnot. Those are not particularly expensive, and it's important to have kind of the necessary wires and guides or else you can't complete the case. From a stent perspective, I mean, we have two different companies' stents on the shelf with pretty similar pricing parity. You know, we have looked at some kind of bulk partnering as far as, you know, hitting a certain spend with a given company over a given year. That does allow some like rebate or discount options. So that is certainly a potential financial consideration. There's not like a single company we work with, but when we look at the spectrum of what we do, because we're both an ASC and an OBL, we look at our device utilization and our coronary stent utilization and our peripheral vascular devices and then make some decisions on that based on kind of the devices we prefer to use. Great. So you answered the question. You're not sole source manufacturer either. Okay, great. As you set up your ASC, Aaron, did you go with a consulting firm or did you try to go with on your own? What happened there? We had some external consulting firms initially, but we primarily went on our own. We don't have any other external investors either. So I think, you know, there definitely was a lot of sweat equity and putting, you know, a lot of, instead of spending time just seeing patients, figuring out the business aspects of the ASC, especially being the first one in the state. So I think it's a pretty big lift up front. But I think myself and the other partners in our group now have kind of really understood the process of doing it. But I do think that getting an upfront kind of manager or someone with experience in the space, if it did it again, probably invest the extra money and time into doing that up front, because there's a lot of headaches that you don't learn about until you're doing them. Okay. From the chat box, from the chat, they said, what habits have been used to decrease the risk of complications? Well, you already answered that you do all radial, so you're not going to have groin bleeds. So good for you. The other question was negotiation with commercial payers. How has that been going for you, Aaron, in your ASC? Yeah, I mean, I think that that's an ongoing discussion. You know, we've got a lot of different commercial payers in Colorado. There's a high penetration of Medicare Advantage plans. And then there's some other, both Kaiser and Intermountain Health have moved in the area with some different insurance packages. So we have actively negotiated with them. And we have had a lot of discussions about, hey, we're offering, especially for some of these capitated programs, a lower cost alternative to some of these procedures that would be done in the hospital setting otherwise. So that is, I think, a potential area where ASCs really have the opportunity to be more nimble than hospital-based systems. Great. And then a couple of questions. Incentivizing your employees and your partners. I mean, do you ever include any equity for the employees or only for partners, physicians? Yeah, we don't have, it's kind of just a physician-owned system. We found that that was easiest. It gets complicated when you have people from multiple kind of levels of training and things from an equity stake standpoint. But I'm sure there are people who have done it differently. Great. And then finally, from my list, what's the most costly mistake you guys made? You know, we built a building from scratch and it was an expensive endeavor. I think a costly mistake we almost made was we have a shell space for two labs and we built out one, and we almost didn't put in a large enough window that can be removed in order to build out the second lab, because it's on the second level of the building and the elevator would be too small to fit the new lab equipment into. So that could have been a multimillion dollar mistake, just kind of thinking about growth plans over time. So that kind of gets back to Kristen and Lori's comment. Kristen, Lori, any comments about what a consulting firm can offer to help avoid some of these potential costly mistakes? Well, I can say definitely we work with folks on their design plans with the focus on patient flow and operations. And, you know, having worked in that space for many, many years, you learn from doing it and the mistakes you've made on other projects. So it's definitely, I think, again, as we titled this webinar, get it right the first time. Great. And then Amy asked the question, I guess to Aaron, how often do you meet to review quality? Do you participate in a registry? Aaron? I mean, we review quality monthly and we have kind of a rotating panel and then have a group meeting of physicians as well. We don't currently yet participate in a registry, but we're looking at doing that. I'm just going to follow that up then. Do you have an internal dashboard that you've created to look at things like, you know, infection or case selection, any bleeding? I know you're mostly radial, but any complications that would happen? We do. Yeah, we kind of create an internal dashboard. I think that's crucial. Great. So do I. That's why I was asking it to understand what you had in place. Yeah, you need partners who are willing to look at themselves with an honest eye too, right? It only takes a couple of complications to sink your ship and then you're all going down together. So that's not great. We want to finish up with some questions from the audience. One question was, are there any Stark law issues? If you're referring your EP case to yourself or to an ASC that you partly own, what's the legal basis for that? Is that going to be biting someone in the back later? Anyone from Corazon able to answer that question? Kristen. I was actually going to defer to Laurie. She she's done a lot of research and there's some exceptions to that. Certainly, we're not attorneys, but we would always defer to having that expert as part of that. So, Laurie, I'm sure you're going to probably say the same thing. Well, that's exactly what I was going to say. Again, from the very beginning, involve your attorney. You don't you want to make sure you don't do anything to raise any red flags. Obviously, self-referral. We all know that's that's a no go. And as Kristen mentioned, making sure your investment is equal to or comparable, equitable to your distribution, that you're doing a third. There's the third one third rule in the AFC that a third of your outpatient procedures should be done in in the facility that you're an owner of. So if you don't have any. I mean, you can operate, you can do procedures in a in a surgery center that you don't own, you just are a credentialed medical staff. But if you own part of the procedure or part of the facility, you have to do cases there. So there's, again, lots of regulatory reasons to engage an attorney to make sure you have everything set up appropriately. But clearly, Aaron, for example, owns part of his equity in there and you're able to refer to your own AFC, right? Yes, but you do have to be really careful with, you know, as was mentioned earlier, if you work in an OBL, it's considered part of the practice income, whereas an AFC is a separate entity. So, for example, right now, we tell the state ahead of time which days our space will be an AFC and which days it will be an OBL. And kind of the way the money flows has important implications for payroll and whatnot as well. And you have to that's a very hard barrier. You have to make sure that they're acting as separate entities. So the OBL days, the OBL is actually renting the space from the AFC entity. Three operations, one building on that line. Yeah. Along that line, a question from the audience. Is there a clinic space? Is it OK to have if you have a hybrid AFC or OBL? My first take on this is, you know, why would you put clinic space in? It seems like expensive place to put it. Lori, does that sound right? Yeah, if you're an AFC, you have to be exclusively an AFC. You cannot have clinic space in an AFC. It has to be temporally or physically separated. And as was just mentioned by Dr. Armstrong, they have to be completely separate businesses as well. Separate tax ID, separate NPI. When it's an OBL, that's part of your practice then. So could you have a clinic there? Sure. But then you're going to end up if you want to change that to an AFC, you're going to have to separate it. Complicated. Very good. Thank you. That's a more clean answer than I would have imagined. OK, so we'll open it up. Any other questions from the audience or the panelists of each other? OK, well, so George asks again, so if it's an AFC OBL hybrid based on certain days, does that mean you can only run clinic on those OBL days? Sounds like that's the case, right, Lori? Yeah. Yes. Yeah. The AFC, again, has to be just completely separate from the practice from the OBL, which is part of the practice. It has to be completely separate. Now, in the hybrid scenario, could you be an AFC in the morning and an OBL in the afternoon? I suppose. But the the difficulty of making that switch is very complicated. Most people that have the hybrid scenario operate it in the same model that Dr. Armstrong described, that it's one day you're in office based lab, the other day you're in AFC. Drew, you're shaking your head. You fully agree with that? Yeah. Keep it clean. Just from a I think from a perspective, you know, the AFC guidelines are really solid and strict. So that's the only way to do it. Makes sense. So, Amy, any final comments you'd like to add as the leader here? I just this was a great discussion. Really appreciate the discussion and the participants, the panelists. It's wonderful. I think to Kristen and Lori's point, and I know we work together so often, is that, you know, this this is the this is the train has left the station. And, you know, understanding what your opportunities are, are really, really important. Yeah, I mean, I would add a Medicare is really in favor of this and a lower cost. I mean, if policy changes happening daily at this point. We don't know if, you know, net neutrality, if site neutrality is coming down the pike as early as a few weeks from now since MedPAC is in favor of it. So, I mean, I think the trend is there. And some people are are considering that some cardiovascular up to 25% of cardiovascular procedures are heading towards an AFC. So I believe this is the future. And I really thank all the panelists and the speakers for their expertise and sharing that with our audience. And I certainly learned a lot. And so I want to thank you all and have a good evening. Thank you. Thanks. Thank you. Thank you.

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